Last reviewed · How we verify
User Performance of the Thunder Plus BGMS
NA trial testing T-PLUS Meter in Diabetes Mellitus in 384 participants. Completed in 31 July 2019.
| Lead sponsor | Ascensia Diabetes Care |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 384 |
| Start date | 10 June 2019 |
| Primary completion | 31 July 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across United States |
Ascensia Diabetes Care
18 and older, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with results within ±15mg/dL of laboratory method at glucose concentration \<100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | 373 |
Count of BGMS Palm (AST) from persons with diabetes within ±15mg/dL of laboratory method at glucose concentration \<100 mg/dL and within ±15% at glucose concentrations ≥100 mg/d results
| Group | Value | 95% CI |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | 344 |
A Labeling evaluation (Ease of Use) was performed by the subjects who answered a survey to evaluate the ease of use of the test and the instructions in the package insert. A numerical score or rating will be reported by subjects for statement. The allowed response are 1) Strongly Disagree, 2) Disagree, 3) Neutral, 4) Agree, or 5) Strongly Agree. The number of responses for each statement that is 3,4, or 5 will be reported; 3,4, and 5 are considered favorable responses.
| Group | Value | 95% CI |
|---|---|---|
| Untrained Subjects WITH Diabetes Respond to a Questionnaire. | 327 |
Number of participant's results from venous blood that are within 15% of the reference analyzer.
| Group | Value | 95% CI |
|---|---|---|
| Untrained Subjects WITH Diabetes Use the T-PLUS BGMS | 327 |
T-PLUS (Thunder PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and CONTOUR PLUS test strips. The meter can wirelessly transmit BG results using Bluetooth® Low Energy technology to the meter mobile application that will be available on specified versions of the iOS and Android mobile platforms. This clinical trial will assess the performance (accuracy) of the T-PLUS meters by lay users enrolled as subjects in the study, and by health care professionals (also called study staff).
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04008836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing